Deputy Manager - Regulatory Affairs

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Piramal Critical Care Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Deputy Manager - Regulatory Affairs Job Description

Publishing and dispatching eCTD submissions for EU-(Human, Vet), TGA, US FDA (Human, Vet), UK (Human, Vet), Canada and GCC countries through established gateways. Document level publishing, document issue resolution, and quality control checks; managing EU and US submissions across the product lifecycle, from initial filings to variations and periodic safety update reports (PSURs). 1)     Responsible for publishing and dispatching eCTD submissions for EU-(Human, Vet), TGA, US‑FDA (Human, Vet), UK (Human, Vet), Canada and GCC countries through established gateways including CESP, ESG NextGen, Syncplicity and MHRA Portal.